[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529059":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":54,"collaborators":56,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":20,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":20,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Intervention (Anti-CD38 antibody)","EXPERIMENTAL","60 enrolled subjects : once a week x 8 doses",[13],"Drug: Anti-CD38 antibody Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Anti-CD38 antibody Injection","intravenous Anti-CD38 antibody administration\n\nThis study adopts a prospective, single arm, open design method. Twenty subjects were enrolled in the study and were treated with Anti-CD38 antibody (16mg\u002Fkg\u002Fw) for 8 weeks.\n\nThe first stage is the main research stage (d1-w8), which is the core treatment period. The subjects will receive intravenous infusion of 16mg\u002Fkg Anti-CD38 antibody once a week for 8 weeks to observe the safety and efficacy during treatment.\n\nThe second stage (w9-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Anti-CD38 antibody after treatment.\n\nThe third stage (w 25 to y 5): Extension visit phase, primarily to observe the long-term safety and sustained efficacy following CD38 monoclonal antibody therapy.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Lei Zhang, MD","Chinese Academy of Medical Science and Blood Disease Hospital","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Ting Sun, MD","CONTACT","+8615822339131","sunting@ihcams.ac.cn",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Yunfei Chen, MD","+8618502220788","chenyunfei@ihcams.ac.cn",[37],{"facility":24,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Tianjin","Tianjin Municipality","300020","China","CN",{"type":45,"coordinates":46},"Point",[47,48],117.17667,39.14222,{"lat":48,"lon":47},[51,53],{"name":28,"role":29,"phone":52,"phoneExt":20,"email":31},"+86-22-23909009",{"name":33,"role":29,"phone":52,"phoneExt":20,"email":35},{"type":55,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[57,59],{"name":58,"class":6},"Beijing Children's Hospital",{"name":60,"class":6},"Tianjin Children's Hospital","100529059","phase-2-anti-cd38-antibody-treating-pediatric-primary-immune-thrombocytopenia-itp-100529059",false,"NCT06168851","Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)","A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Pediatric Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n* Age 6 years and above, male or female\n* Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)\n* Diagnosis of ITP ≥3 months, and with a platelet count of \\\u003C30 X 10\\^9\u002FL measured within 2 days prior to inclusion\n* Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab or TPORAs.\n* The previous emergency treatment of ITP (e.g. methylprednisolone, platelet transfusion, IVIG transfusion) must be completed at least 2 weeks before the first administration\n* Signed and dated written informed consent\n* With normal hepatic and renal functions\n* ECOG physical state score ≤ 2 points\n* Cardiac function of the New York Society of Cardiac Function ≤ 2\n* Patients receiving maintenance treatment (including corticosteroids (less than or equal to 0.5mg\u002Fkg prednisone), TPO receptor agonists, etc.) must have a stable dose at least 4 weeks before the first administration, and azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first administration; The end of rituximab treatment was\\>3 months；More than 6 months after splenectomy.\n\nMarch 26,2024 After approval by the Ethics Committee，age of subjects has been modified to 6 years and above upon enrollment. Approval Number: IIT2023072-EC-2.\n\nExclusion Criteria:\n\n* Allergy to daratumumab or its excipients, or prior treatment with daratumumab that was refractory or achieved a response lasting \\\u003C6 months；\n* Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases;\n* HIV positive;\n* Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive;\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.;\n* At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled;\n* Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis;\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past;\n* Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;\n* Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;\n* Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.);\n* Patients with septicemia or other irregular severe bleeding;\n* Patients taking antiplatelet drugs at the same time;\n* Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.","ALL","6 Years","17 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including Anti-CD20 Antibody and\u002For TPO-RA, or those in whom no other second-line treatment options are suitable.",[79,80],"Immune Thrombocytopenia","Treatment","2025-11-21",{"date":83,"type":84},"2025-11-28","ACTUAL",{"date":86,"type":84},"2023-12-28",{"date":88,"type":73},"2030-12",{"name":5,"class":6},1]